Flexible API clinical trial material development and cGMP assets to support your chemical synthesis
As part of our comprehensive product development for drug substances and intermediates, we provide phase-appropriate clinical trial material for feasibility studies, early and late phase clinical trials. In addition to R&D and kilo-Lab capabilities in both our Visp (CH) and Nansha (CN) facilities (20-50L vessels), we have dedicated small-scale and launch-scale facilities to support early stage and late-stage clinical trial programs, respectively.
Specialized HPAPI R&D labs and small-scale plants are available to support early phase clinical to low volume commercial production of highly potent compounds (down to OEL ≥ 1ng/m3) and ADC payloads.
Clinical trial material labeling and quality requirements
Our R&D pilot plants and small-scale plants adhere to strict global quality standards and facilitate seamless technical transfer into our launch and commercial-scale-facilities. Our QA and regulatory services teams provide all data, information, and support required for the CMC portion of regulatory findings.
| Small Scale Plant Visp |
Small Scale Plant Nansha |
Mid Scale Plant Visp |
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|---|---|---|---|
| Purpose | Campaigns for projects in early clinical phase to low volume commercial API/Intermediates production | Campaigns for projects in early clinical phase to low volume commercial API/Intermediates production | Campaigns for projects in clinical phase to commercial API/Intermediates and HPAPI production |
| Equipment |
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| Some Special Features |
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| OEL | >1μg/m3 | >10μg/m3 | >100ng/m3 |
| Quality Aspects |
GMP ISO FDA Swissmedic |
GMP ISO |
GMP ISO FDA Swissmedic |
R&D deliverables based on customer technology, regulatory and development API needs
We focus on customer technology, regulatory and development API needs, to deliver:
- Feasibility studies which include: development of innovative processes and 2nd generation processes (1-3 months)
- Small scale quantities (10–100 kg, 3–10 chemical steps; APIs) (2-3 months)
- Process development production of launch quantities (100 kg –5 tons), full regulatory support, validated processes (APIs, HPAPIs) (3-6 months)
- Support of direct API technology transfers from clients to our industrial plants (1-3 months)
We provide cost-competitive manufacturing on an industrial scale by optimizing chemical processes, utilizing advanced PAT and minimizing unit operations, supported by specialized quality control and quality assurance expertise.
Development and optimization of chemical processes
We have experience in many types of advanced chemical synthesis techniques. We are always prepared to adapt and optimize your process or offer you many advanced techniques of our own. In either case, our experienced team can provide you with successful development technologies for all of your chemical processing needs.
Our Advanced Chemical Synthesis Technologies Include:
| Technology | Example |
|---|---|
| Hazardous and Highly Reactive Chemicals | HCN, ClCN, chlorosulfonyl isocyanate, SOCl2, Cl2 (gas/liquid), ketene, diketene, phosgene (cGMP), CO, acetylene, ethylene |
| Organometallic Reactions | Grignard, organolithium, sodium in liquid NH3, organozinc reactions, Heck reactions, Suzuki cross-couplings |
| Reductions | Catalytic hydrogenation (homogeneous and heterogeneous), metal hydrides (NaBH4, LiAIH4), Raney nickel |
| Oxidations | With ozone (batch and continuous), peroxides, oxygen/air, nitric acid, ammoxidation |
| Reactions Under Special Conditions |
Low-temperature reactions (-90°C) |
| Asymmetric Reactions | Transition metal catalysts (hydrogenation, oxidation, Heck/Aldol), biocatalysts, racemic separation, use of chiral building blocks |